Ropivacaine hydrochloride for Hip osteoarthritis | Postoperative pain

Inclusion criteria

• {"criterion_text":"- 18 – 80 years of age\n- Scheduled for a primary elective total hip arthroplasty\n- Patient must be a candidate for same day discharge as determined by local guidelines that will be published separately (incl. ASA 1-2, BMI < 35)\n- Informed consent understood and signed\n- Patient is 160 -186 cm tall"}

Exclusion criteria

• {"criterion_text":"- Scheduled bilateral THA\n- Language barrier preventing completion of study form in Finnish\n- Pregnancy or breastfeeding\n- Chronic pain syndrome\n- Contraindication to or failed spinal anesthesia\n- Allergy or contraindication to NSAIDs (e.g. chronic anti-coagulant use)\n- Diabetes requiring insulin medication\n- Preoperative chronic use of illegal substances\n- Renal insufficiency (eGFR < 60)\n- Unstable psychiatric conditions\n- Severe neurological disorder\n- Cognitive deficiencies preventing informed consent"}

Primary endpoints

• {"endpoint_text":"- Return of sensory and motor function","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Post-operative pain evaluated using the Numeric Rating Scale (NRS)","definition_or_measurement_approach":"Measured using the Numeric Rating Scale (NRS)"}
• {"endpoint_text":"- Urinary retention","definition_or_measurement_approach":""}
• {"endpoint_text":"- Post-operative nausea and vomiting","definition_or_measurement_approach":""}
• {"endpoint_text":"- Postoperative opioid consumption in morphine milligram equivalents (MME)","definition_or_measurement_approach":"Measured as opioid consumption converted to morphine milligram equivalents (MME)"}
• {"endpoint_text":"- Patient satisfaction will be evaluated using a 5-point Likert scale","definition_or_measurement_approach":"Measured using a 5-point Likert scale"}
• {"endpoint_text":"- Perioperative hemodynamics","definition_or_measurement_approach":""}
• {"endpoint_text":"- Onset time of block","definition_or_measurement_approach":"Time to onset of sensory/motor block (as stated)"}
• {"endpoint_text":"- Adequacy of anesthesia","definition_or_measurement_approach":""}
• {"endpoint_text":"- Same day discharge rate","definition_or_measurement_approach":"Proportion of patients discharged same day"}
• {"endpoint_text":"- Length of stay in the postoperative care unit and length of hospital stay","definition_or_measurement_approach":"Measured as duration/time in postoperative care unit and total hospital stay"}

Finland

Earliest CTIS Part Ii Submission Date

19-10-2025

Latest Decision Or Authorization Date

30-04-2026

Processing Time Days

193

Number Of Sites

1

Number Of Participants

162

Primary sponsor

Full Name

Turku University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Finland

Third parties

• {"country":"","full_name":"Finnish State Research Funding (VTR) for university level health research.","duties_or_roles":"Source of monetary support","organisation_type":""}